MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 110MM, STERILE 2 PACK; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	143110
Medical Device Problem Codes	Break (1069); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
Event or Problem Description
As reported: "3.2 x 110 pin tip broke off in patient's right tibia during insertion for placement of mako tibial tracker".Rep reported that no further information is available from the hospital or surgeon.Update 06/march/2019: spoke to rep.Broken portion of the pin was left in the patient.Rep confirmed there was absolutely no surgical delay.Case type tka.Surgery was not completed manually.
Event or Problem Description
As reported: "3.2 x 110 pin tip broke off in patient's right tibia during insertion for placement of mako tibial tracker".Rep reported that no further information is available from the hospital or surgeon.Update 06/march/2019: spoke to rep.Broken portion of the pin was left in the patient.Rep confirmed there was absolutely no surgical delay.Case type tka.Surgery was not completed manually.
Additional Manufacturer Narrative
Reported event: it was reported that the bone pin fractured when drilling.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Product history review: review of the product history records indicate 366 devices were manufactured under lot w56528-2 and accepted into final stock on 4/24/2018.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 143110, lot w56528-2 shows no additional complaints related to the failure in this investigation.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been an ncs 1470754 and capa 1480798 are associated with the product and failure mode reported in this event.Device not returned.

• Brand Name: BONE PIN, 3.2MM X 110MM, STERILE 2 PACK
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8425989
• Report Number: 3005985723-2019-00236
• Device Sequence Number: 19375759
• Product Code: OLO
• UDI-Device Identifier: 00848486018139
• UDI-Public: 00848486018139
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 143110
• Device Lot Number: W56528-2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 55 YR